Biotech Values

[biomaven0]

what was the EMA rationale for restricting Iclusig use to second generation TKI failures.

Because that was the population of the trials to date, and that is where the medical need is greatest.

The FDA took a more generous (and in my view sensible) approach, and reasoned that if the drug works well in patients that had failed the 2nd-line drugs it would also work well in patients that had failed only Gleevec. But that position required something of a leap beyond the actual data presented (not too hard a leap given the FDA had already made a similar judgement for bosutinib).

Once the company has some actual data in 1st/2nd line, I'm sure the EMA will expand the label. And from a pricing perspective, the narrower label might actually help with negotiations on price.

Peter